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Antibiotic Development: As FDA’s QIDP List Grows Longer, Will Firms GAIN Less?

 
• By Derrick Gingery

So far, FDA has issued 24 Qualified Infectious Disease Product designations for 16 chemical entities, including to several products for the same infection; Cubist official says products also will have to show value.

Sponsors might soon be facing a new regulatory dilemma in the antibiotic space – the risks of FDA trying to go too fast with product reviews. The agency has made a large number of qualified infectious disease product (QIDP) designations, meaning that FDA will have to devote considerable resources to expediting eventual applications.

The volume of designations could run the risk of straining FDA and even firms as they aim to move the...

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Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 
• By Eliza Slawther

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 
• By Sarah Karlin-Smith

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
• By Cathy Kelly

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.